Brachytherapy clip and applicator

ABSTRACT

A surgical implant includes a biocompatible member configured for securement to an underlying target surgical site and a radiation source integrated into or onto the biocompatible member. The surgical implant may be one of a clip, pin, or coil and the radiation source includes at least one brachytherapy capsule, or other radioactive material incorporated therein or provided thereon. The radioactive material provides a dose of radiation to the target surgical site. The surgical implant may also be formed from titanium, stainless steel or polymers. A surgical applier is provided for allowing a surgeon to apply the implant to a patient&#39;s tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation application claiming thebenefit of and priority to U.S. patent application Ser. No. 14/989,406,filed Jan. 6, 2016, the entire content of which is hereby incorporatedby reference herein.

BACKGROUND 1. Technical Field

The present disclosure relates to surgical implants, clips or fastenersand, more particularly, to surgical low dose brachytherapy implants,clips or fasteners and applicators therefor.

2. Background of Related Art

Generally, brachytherapy is an advanced form of cancer treatment.Specifically, permanent radioactive seeds, sutures, buttresses or thelike are placed in or near the cancer site itself, which radioactiveseeds, sutures or buttresses emit a relatively low dose of radiationdirectly to the cancer site while reducing exposure of surroundinghealthy tissue to the radiation.

Depending on the underlying cancer to be treated and on the underlyingtissue, particular dosimetry guidelines have been developed for theplacement of radioactive seeds, sutures or buttresses and for theradiation levels emitted by the radioactive seeds, sutures orbuttresses. Generally, the placement of such radioactive seeds, suturesor buttresses are at predefined distances relative to one another inorder to enable effective dosimetry. The radioactive sutures and/orbuttresses generally include radioactive seeds incorporated therein,which have been placed at fixed, uniform distances to one another.

In view thereof, a need exists, and it is desirous, for surgicalbrachytherapy implants, clips or fasteners, which may be placed at anydesired location relative to the target cancer site. The need alsoexists, and it is desirous, for an apparatus capable of placing,individually, the surgical brachytherapy implants, clips or fasteners.The brachytherapy implant can be configured as a staple, clip, pin,tack, coil or other implant, to name a few.

The need also exists, and it is desirous, for methods of using thesurgical brachytherapy implants, clips or fasteners, and/or theapparatus for placing, individually, the surgical brachytherapyimplants, clips or fasteners.

SUMMARY

The present disclosure relates to surgical implants, clips, and/orfasteners.

According to an aspect of the present disclosure, a surgical implant isprovided comprising a biocompatible member configured for securement toan underlying target surgical site and a radiation source integratedinto or onto the biocompatible member.

The surgical implant may be one of a clip, pin, or coil and theradiation source includes at least one brachytherapy capsule providing adose of radiation to the target surgical site. The surgical implant mayalso be formed from titanium, stainless steel or polymers.

According to another aspect of the present disclosure, the clipcomprises a deformable backspan, wherein a first leg extends from afirst end of the backspan and a second leg extends from a second end ofthe backspan, and wherein the first leg and the second leg extendsubstantially in the same direction from the backspan.

A biocompatible radioactive material may be dispersed throughout thesurgical implant such that the entirety of the surgical implantirradiates radioactively. The surgical implant may also be coated withone of gold or a colored oxide layer such that the surgical implant issubstantially visible in the surgical field during an open procedure orradiographic location.

According to another aspect of the present disclosure, the pin comprisesa leg having a proximal end and a distal end and a head extending fromthe proximal end of the leg at an angular orientation relative to alongitudinal axis of the leg. The pin may include a barb extending fromthe distal end of the leg and may further include a barb extending froma free end of the head.

According to still another aspect of the present disclosure, the coilcomprises a body portion having a first end and a second end oppositethe first end, the first end of the body portion having a sharp tissuepenetrating point, and the second end having a tang disposed generallyinward toward the center of the body portion. The body portion mayinclude approximately 2.5 coils.

According to yet another aspect of the present disclosure, a method ofperforming a surgical procedure at a target surgical site may beprovided. The method may comprise providing a surgical applier loadedwith at least one surgical implant, wherein the at least one surgicalimplant includes a biocompatible member configured for securement to anunderlying target surgical site and a radiation source integrated intoor onto the biocompatible member, placing the surgical applier adjacentto a first location of the target surgical site, and firing the surgicalapplier to secure a first surgical implant of the at least one surgicalimplant to the first location of the target surgical site.

The method may further comprise relocating the surgical applier to asecond location of the target surgical site and re-firing the surgicalapplier to secure a second surgical implant of the at least one surgicalimplant to the second location of the target surgical site.

The method may further include relocating the surgical applier at aplurality of locations of the target surgical site and re-firing thesurgical applier to secure a surgical implant of the at least onesurgical implant to each respective location of the plurality oflocations of the target surgical site. Additionally, the method mayfurther include relocating the surgical applier at the plurality oflocations of the target surgical site and arranging the at least onesurgical implant in any configuration, in any pattern, or in anyquantity.

A surgical implant of the at least one surgical implant in the form ofone of a clip, pin, or coil may also be provided wherein the radiationsource is at least one brachytherapy capsule providing a dose ofradiation to the target surgical site. A surgical implant of the atleast one surgical implant wherein a biocompatible radioactive materialis dispersed throughout the surgical implant such that the entirety ofthe surgical implant irradiates radioactively may also be provided.

According to still another aspect of the present disclosure, a surgicalapplier is provided. The surgical applier may comprise a handle assemblyand an endoscopic shaft assembly rotatably supported on and extendingfrom the handle assembly, the endoscopic shaft assembly configured toarticulate off-axis, the endoscopic shaft assembly including an endeffector supported at a distal end of the endoscopic shaft assembly, anda plurality of surgical implants loaded therein, wherein a distal-mostsurgical implant of the plurality of implants is disposable in the endeffector and is fired by the end effector upon an actuation of thehandle assembly, each surgical implant includes a biocompatible memberconfigured for securement to an underlying target surgical site, and aradiation source integrated into or onto the biocompatible member.

The surgical applier may further comprise a cartridge loaded with theplurality of surgical implants wherein the endoscopic shaft assembly isconfigured to selectively receive the cartridge. The plurality ofsurgical implants may be one of a clip, pin, or coil and the radiationsource is at least one brachytherapy capsule providing a dose ofradiation to the target surgical site.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will be further described with reference to theaccompanying drawings, wherein like reference numerals refer to likeparts in the several views, and wherein:

FIGS. 1-5 are plans views of various surgical implants in accordancewith embodiments of the present disclosure;

FIG. 6 is a plan view of another embodiment of a surgical implant inaccordance with the present disclosure;

FIGS. 7 and 8 are perspective views of yet another embodiment of asurgical implant in accordance with the present disclosure;

FIG. 9 is a perspective view of a surgical applying apparatus accordingto an embodiment of the present disclosure, for applying the surgicalimplants of FIGS. 1-5; and

FIG. 10 is a perspective view of a surgical applying apparatus accordingto another embodiment of the present disclosure, for applying thesurgical implants of FIGS. 7 and 8.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed surgical applying apparatus, andsurgical marker or implant, will now be described in detail withreference to the drawings, in which like reference numerals designateidentical or corresponding elements in each of the several views. In thedrawings and in the description that follows, the term “proximal” willrefer to the end of the applying apparatus which is closest to theoperator, while the term “distal” will refer to the end of the applyingapparatus which is farthest from the operator.

In accordance with the present disclosure, as illustrated in FIGS. 1-5,a surgical implant or clip 100 is provided and includes a backspan orcrown 102, a first leg 104 extending from a first end of backspan 102,and a second leg 106 extending from a second end of backspan 102. Thefirst leg 104 and the second leg 106 may extend in the same directionfrom backspan 102.

Surgical clip 100 may have an unformed condition wherein the first leg104 and the second leg 106 are parallel, or substantially parallel, toone another and spaced a relative distance from one another. Surgicalclip 100 may have a formed condition wherein the first leg 104 and thesecond leg 106 are parallel, or substantially parallel, to one anotherand in relative close approximation to one another. In embodiments,first leg 104 and second leg 106 are substantially out of parallelrelative to one another.

Surgical clip 100 may be fabricated from a formable material, such as,for example, titanium, stainless steel or polymers. In this manner,surgical clip 100 may be introduced over a target vessel or tissue whilein an unformed condition, and then formed or fastened onto the targetvessel or tissue to secure the surgical clip 100 to the target vessel ortissue. It is contemplated that surgical clips 100 may be fabricatedfrom any non-degradable, biocompatible material known by those havingskill in the art.

In accordance with the present disclosure, as illustrated in FIG. 1,surgical clip 100 may include a brachytherapy capsule or seed 110, orthe like, integrated into backspan 102 thereof. It is contemplated, asillustrated in FIG. 2, that multiple brachytherapy capsules 110 may beintegrated into backspan 102 of surgical clip 100. It is furthercontemplated, as illustrated in FIGS. 3 and 4, that at least onebrachytherapy capsule 110 may be secured to an outer surface (e.g.,distal, proximal or side) of backspan 102 of surgical clip 100.

Also in accordance with the present disclosure, as illustrated in FIGS.2, 3 and 4, surgical clip 100 may include a brachytherapy capsule 110,or the like, integrated into first leg 104 and/or second leg 106thereof. It is contemplated that multiple brachytherapy capsules 110 maybe integrated into first leg 104 and/or second leg 106 of surgical clip100. It is further contemplated that at least one brachytherapy capsule110 may be secured to an outer surface (e.g., inboard, outboard or side)of first leg 104 and/or second leg 106 of surgical clip 100.

Any other combinations of placement of brachytherapy capsules 110 alongor integration of brachytherapy capsules 110 in surgical clip 100 iscontemplated and within the scope of the present disclosure.

Each brachytherapy capsule 100 may include a radioactive materialdisposed in a shell, or a radioactive material disposed on or throughouta solid body, wherein the radioactive material includes any of a numberof radioactive isotopes. Possible low dose isotopes include, but are notlimited to, Cesium-131 (¹³¹Cs), Iridium-192 (¹⁹²Ir), Iodine-125 (¹²⁵I),Palladium-103 (¹⁰³Pd), and Ytterbium-169 (¹⁶⁹Yb). Therapeutic dosagesmay range from 80 to 150 Gy depending on the isotope and desiredexposure. Surgical clip 100 may have various target energies to provideflexibility in dosimetry planning.

It is envisioned that brachytherapy capsules 100 constitute a radiationsource and may be dimensioned so as to produce a particular strength ofradiation field therefrom, and/or a particular geometry of the radiationfield therefrom.

It is further envisioned, as illustrated in FIG. 5, that surgical clip100 may be processed such that the entirety of surgical clip irradiatesradioactively from radioactive material 120 dispersed throughoutsurgical clip 100. For example, and within the purview of the presentdisclosure, surgical clip 100 may be processed so as to provide a knowndegree of radiation field strength. Specifically, in an embodiment,surgical clip 100 may be a polymeric surgical clip fabricated from aradioactive biocompatible material.

In an embodiment, surgical clips 100 are constructed to be visible inthe surgical field during either an open or a laparoscopic procedure.Surgical clips 100 may be coated with a material, such as, for example,gold, or coated with a colored oxide layer to make surgical clips 100relatively more visible. Gold coatings or other coatings may be utilizedto enable radiographic location of surgical clips 100 during follow-upprocedures. In this manner, surgical clips 100 may serve as fiduciarymarkers.

In accordance with the present disclosure, by fastening the surgicalclip 100 onto a target vessel or tissue, a therapeutic dose of radiationcan be applied to a set location and known volume of tissue based on theactivity and isotope material of the brachytherapy capsule 110.

Surgical clips 100 serve the purpose of applying a local therapeuticdose of radiation to, for example, a tumor or to a resection site afterremoval of a cancerous tumor. Surgical clips only require sufficientmechanical strength to hold brachytherapy capsule 110 in place and arenot intended to hold tissue structures together.

Surgical clips 100 may be applied or fastened to any number of tissueshaving a tumorous growth, such as, for example lung tissue, solidorgans, gastro-intestinal tissue, and soft tissues.

In accordance with the present disclosure, it is envisioned thatsurgical clips 100 may be applied separately, and individually, at alocation of choice by the attending clinician. Since brachytherapycapsule 110 has a set three-dimensional field of known radiationstrength and geometry, multiple individual surgical clips 100 may beapplied to the target tissue to enable effective dosimetry.

It is contemplated that surgical clips 100 may be applied or arranged inany configuration, pattern, or quantity to achieve the intended purpose.For example, surgical clips 100 may be arranged in, for example, astraight line, arcuate, triangular, rectangular, circular or otherconfiguration. It is further contemplated that surgical clips 100 may befastened to the target tissue a uniform distance from one another,various distances from one another, or a combination thereof.

In certain instances, uniform and accurate spacing of surgical clips 100is desired. For example, if spacing between adjacent surgical clips 100is not accurate then the desired dosimetry may not be achieved.

In accordance with the present disclosure, while a surgical implant, inthe form of a clip 100 has been shown and described in detail, it iscontemplated that the surgical implant may include, and is not limitedto, a surgical pin, a surgical tack, a surgical coil or the like. Asmentioned above, and as contemplated herein, any of the surgicalimplants may be fabricated from a biocompatible material, such as, forexample, titanium, stainless steel or polymers. Likewise, as mentionedabove, and as contemplated herein, any of the surgical implants mayincorporate therein or support thereon a brachytherapy capsule 110, ormay be processed such that the entirety of surgical implant irradiatesradioactively.

For example, with reference to FIG. 6, a surgical implant in the form ofa surgical pin is shown and generally designated as 200. Surgical pin200 may include a leg 204 having a proximal end 204 a (not shown) and adistal end 204 b (not shown), and a head or arm 202 extending fromproximal end 204 a. Head 202 may extend orthogonally from a longitudinalaxis of leg 204 or at any desired angular orientation relative to thelongitudinal axis of leg 204. It is contemplated that surgical pin 200may include a barb 206 or the like projecting from distal end 204 b ofleg 204. It is further contemplated that surgical pin 200 may include abarb or tang 208 projecting distally from a free end of head or arm 202,wherein tang 208 functions to help fix an orientation of surgical pin200 in the target tissue following implantation.

In accordance with the present disclosure, at least one brachytherapycapsule 110 may be disposed within or onto head 202 of surgical pin 200,or may be disposed within or onto leg 204 of surgical pin 200. It isfurther envisioned that surgical pin 200 may be processed such that theentirety of surgical pin irradiates radioactively from radioactivematerial dispersed throughout surgical pin 200. For example, and withinthe purview of the present disclosure, surgical pin 200 may be processedso as to provide a known degree of radiation field strength.

Surgical pin 200 may be fabricated from, for example, titanium,stainless steel or polymers. In an embodiment, surgical pin 200 may be apolymeric surgical pin fabricated from a radioactive biocompatiblematerial. Some examples of non-degradable biocompatible polymers includepolyolefins such as polyethylenes and polypropylenes, nylons,polyesters, silicones, polyimides, polymethylmethacrylates,polyurethanes, PTFE, polyethersulfone, polysulfone, PEEK, to name a few.

As an additional example, with reference to FIGS. 7 and 8, a surgicalimplant in the form of a surgical tack or coil is shown and generallydesignated as 300. Specifically, surgical tack 300 is a helical-shapedcoil fastener. Surgical tack 300 is designed for application to tissueby rotating surgical tack 300 into and through the target tissue.Surgical tack 300 generally includes a coil body portion 302, havingapproximately 2½ coils and terminating in a sharp tissue penetratingpoint 304. Surgical tack 300 includes a tang 306 at an opposite end ofcoil body portion 302 from penetrating point 304. Tang 306 extendsgenerally inwardly toward the center of coil body portion 302.

In accordance with the present disclosure, at least one brachytherapycapsule 110 may be disposed within or onto tang 306 of surgical tack300, or may be disposed within or onto coil body portion 302 of surgicaltack 300. It is further envisioned that surgical tack 300 may beprocessed such that the entirety of surgical tack irradiatesradioactively from radioactive material dispersed throughout surgicaltack 300. For example, and within the purview of the present disclosure,surgical tack 300 may be processed so as to provide a known degree ofradiation field strength.

Surgical tack 300 may be fabricated from, for example, titanium,stainless steel or polymers. In an embodiment, surgical tack 300 may bea polymeric surgical coil fabricated from a radioactive biocompatiblematerial.

While surgical implants in the form of clips, pins and coils have beenillustrated and described herein, it is within the scope of the presentdisclosure that the surgical implants may also include two-partfasteners, tacks, locking hinged fasteners, staples or the like.

In order to place surgical clips 100 disclosed herein, in accordancewith the present disclosure, as illustrated in FIG. 9, a surgicalapplier 400 is provided. Surgical applier 400 includes a handle assembly410, and an endoscopic shaft assembly 420 extending from handle assembly410. Endoscopic shaft assembly 420 is rotatably connected to handleassembly 410 such that endoscopic shaft assembly 420 is rotatable abouta longitudinal axis “X1-X1” thereof. Endoscopic shaft assembly 420 mayinclude a proximal portion 422, and a distal portion 424 pivotablyconnected to proximal portion 422, wherein distal portion 424 may bearticulated relative to proximal portion 422.

Distal portion 424 of endoscopic shaft assembly 420 may include aquantity of surgical clips 100 (not shown) pre-loaded therein, or may beconfigured to selectively receive a cartridge assembly (not shown) whichis loaded with a quantity of surgical clips 100 therein. For example,the cartridge assembly may be loaded with ten or fewer surgical clips100, or any quantity of surgical clips 100.

Distal portion 424 of endoscopic shaft assembly 420 may include a firingand forming mechanism configured to load a single (e.g., distal-most)surgical clip 100 into a pair of jaws 430, and to form the surgical clip100 loaded into the pair of jaws 430. Surgical applier 400 is configuredto fire and form a single surgical clip 100 during a complete firingsequence.

For a more detailed description of the construction and operation of anexample of a surgical applier 400, reference may be made to U.S. Pat.No. 8,403,946, the entire content of which is incorporated herein byreference.

In order to place surgical tacks 300, in accordance with the presentdisclosure, a tack applier 500 (FIG. 10) may be provided which is eitherpre-loaded with surgical tacks 300, or which may selectively receive acartridge loaded with surgical tacks 300. The tack applier 500 may beconfigured to fire or deliver a single surgical tack 300 during a fullfiring sequence. The tack applier 500 may also be configured toarticulate in order to facilitate the firing of surgical tacks 300therefrom.

For a more detailed description of the construction and operation of anexample of a surgical tack applier 500 capable of firing surgical tacks300, reference may be made to U.S. Pat. No. 5,830,221, the entirecontent of which is incorporated herein by reference.

In accordance with the present disclosure, the combination of surgicalimplants and appliers disclosed herein provides the clinician arelatively great deal of flexibility and customization in placingradiation emitting implants (e.g., surgical clips 100, surgical pins200, surgical tacks 300, etc.) at desired target surgical sites, wherebythe applier (e.g., surgical applier 400) is articulatable and/orrotatable to provide the clinician with increased flexibility andprecision in placing the radiation emitting implants.

It is contemplated for example, that a geometry of surgical clip 100,surgical pin 200 and surgical tack 300; and a geometry of a tip (e.g.,the pair of jaws, etc.) of a surgical applier may be optimized to worktogether as location guides to optimally place surgical clip 100,surgical pin 200 and/or surgical tack 300 adjacent to one another,wherein the brachytherapy capsule 100 has a known geometry and radiationfield strength, to achieve effective dosimetry.

In accordance with the present disclosure, the location of placement ofsurgical clips 100, surgical pins 200 and/or surgical tacks 300 is notlimited to a predefined geometry, pattern, density, or the like. Inparticular, as mentioned above, surgical clips 100, surgical pins 200and/or surgical tacks 300 may be fastened to a target tissue site in anygeometry, pattern and/or density, as the clinician desires or needs.

By way of example, the ability to fasten surgical clips 100, surgicalpins 200 and/or surgical tacks 300, to a target tissue site (e.g., lungtissue in a lung resection procedure), in any geometry, pattern and/ordensity, may be quite useful in a lung cancer patient, where many lungcancer patients suffer from impaired lung volume and cannot tolerateunnecessary loss of lung volume, and may need multiple rows ofbrachytherapy sources to ensure treatment of an inadequately narrowsurgical margin.

In any of the embodiments disclosed herein, the surgical implants (e.g.,surgical clips 100, surgical pins 200 and/or surgical tacks 300) may beincorporated into, or configured for use with, devices that are part ofa powered surgical system or robotic surgical system.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appendedthereto.

What is claimed is:
 1. A surgical implant comprising: a proximal halfincluding: a proximal portion of a coil body portion, the proximalportion having a proximal end; and a tang extending from the proximalend of the coil body portion; and a distal half including: a distalportion of the coil body portion, the distal portion having a distal endterminating in a sharp tip: and a plurality of radiation sourcesdisposed in or on the proximal half, the plurality of radiation sourcesintegrated into or onto the proximal portion of the coil body portion orthe tang, wherein each of the proximal portion of the coil body portionand the tang includes more than one radiation source of the plurality ofradiation sources.
 2. The surgical implant according to claim 1, whereinthe plurality of radiation sources are brachytherapy seeds.
 3. Thesurgical implant according to claim 2, wherein the brachytherapy seedsare integrated into the coil body portion.
 4. The surgical implantaccording to claim 2, wherein the brachytherapy seeds are secured to anouter surface of the coil body portion.
 5. The surgical implantaccording to claim 2, wherein the brachytherapy seeds are integratedinto the tang.
 6. The surgical implant according to claim 2, wherein thebrachytherapy seeds are secured to an outer surface of the tang.
 7. Thesurgical implant according to claim 1, wherein the coil body portionincludes 2.5 coils.
 8. The surgical implant according to claim 7,wherein the coil body portion includes a proximal coil and a distalcoil, and the plurality of radiation sources are disposed in or on theproximal coil.
 9. The surgical implant according to claim 1, wherein thecoil body portion is wound in a plurality of coils around a centrallongitudinal axis defined through the coil body portion.
 10. Thesurgical implant according to claim 9, wherein the plurality of coilsfollows a helical path.
 11. The surgical implant according to claim 1,wherein the tang extends inwardly toward a center of the coil bodyportion.
 12. The surgical implant according to claim 1, wherein thedistal half is free of a radioactive source.
 13. A method of performinga surgical procedure at a target surgical site, the method comprising:placing a surgical applier adjacent to a first location of a targetsurgical site; and firing a first surgical implant from the surgicalapplier into the first location, the first surgical implant including: aproximal half including: a proximal portion of a coil body portion, theproximal portion having a proximal end; and a tang extending from theproximal end of the coil body portion; and a distal half including: adistal portion of the coil body portion, the distal portion having adistal end terminating in a sharp tip: and a plurality of radiationsources disposed in or on the proximal half, the plurality of radiationsources integrated into or onto the proximal portion of the coil bodyportion or the tang, wherein each of the proximal portion of the coilbody portion and the tang includes more than one radiation source of theplurality of radiation sources.
 14. The method according to claim 13,further comprising: moving the surgical applier adjacent to a secondlocation of the target surgical site; and firing a second surgicalimplant from the surgical applier into the second location.